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OIG Approves Pharmacy’s Provision of Free or Below Market Value Items in Limited Circumstances

December 12, 2012 | Blog | By Karen Lovitch, Theresa Carnegie, Carrie Roll

Last Friday, the Office of Inspector General (OIG) issued Advisory Opinion No. 12-19 approving three of four proposed arrangements involving a pharmacy’s provision of free or below market items and services to community homes where the pharmacy’s patients reside.
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Off Label Marketing - First Amendment Challenge Ruling

December 6, 2012 | Blog | By Daria Niewenhous

The U.S. Court of Appeals for the 2nd Circuit upheld a First Amendment challenge to the federal prosecution of pharmaceutical salesperson Alfred Caronia for off-label marketing. Given the number of off-label marketing cases pursued by the government in recent years, this decision could have major repercussions. 
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ML Strategies Publishes Weekly Health Care Reform Update on December 3, 2012

December 5, 2012 | Blog | By Daria Niewenhous

ML Strategies has posted its weekly Health Care Reform Update.  This publication provides timely and concise information on  implementation of the Affordable Care Act, and other state and federal administrative and legislative activities related to health care reform.
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OCR Issues Guidance on Methods for De-Identification of PHI Under HIPAA

November 28, 2012 | Blog | By Karen Lovitch

On November 26th, the U.S. Department of Health and Human Services Office for Civil Rights (OCR) released guidance on the methods that covered entities and business associates can use to de-identify protected health information (PHI) in accordance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule.
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DOJ and SEC Issue Highly Anticipated FCPA Guidance

November 15, 2012 | Blog | By Karen Lovitch

On November 14th, the U.S. Department of Justice (“DOJ”) and the U.S. Securities and Exchange Commission (“SEC”) published A Resource Guide to the U.S. Foreign Corrupt Practices Act, their long-awaited, highly anticipated guidance on the FCPA.
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ML Strategies Publishes Weekly Health Care Reform Update on November 12, 2012

November 14, 2012 | Blog | By Daria Niewenhous

ML Strategies has posted its weekly Health Care Reform Update.  This publication provides timely and concise information on  implementation of the Affordable Care Act, and other state and federal administrative and legislative activities related to health care reform.
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Affordable Care Act Implementation During Obama’s Second Term

November 7, 2012 | Blog | By Karen Lovitch, Alexander Hecht

My Mintz Levin colleague, Stephen Bentfield, and Alex Hecht of ML Strategies provide their perspective on the future direction of the Affordable Care Act (ACA) during President Obama’s second term in a Law360 article entitled What Obama’s Re-Election Means for Health Care Policy.
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Medical Marijuana: Weeding Through the New Massachusetts Law

November 7, 2012 | Blog | By Daria Niewenhous, Dianne Bourque

Massachusetts voters passed a referendum question eliminating state criminal and civil penalties for the medical use of marijuana by patients with certain “debilitating medical conditions,” including cancer, glaucoma, HIV, AIDS, hepatitis C, Crohn’s disease, Parkinson’s disease, ALS, or multiple sclerosis.
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2013 Medicare Physician Fee Schedule: Issues of Interest to Independent Laboratories

November 2, 2012 | Blog | By Karen Lovitch

Yesterday the Centers for Medicare & Medicaid Services (CMS) published a final rule with comment period implementing the Medicare Physician Fee Schedule for 2013, and it covers a number of  issues of interest to independent laboratories.
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House Committee Moving Forward with Subpoena Regarding Medicare Advantage Demonstration Project

October 22, 2012 | Blog | By Karen Lovitch, Theresa Carnegie

As discussed in our recent post on the new Medicare Advantage (MA) star ratings, there is ongoing controversy regarding HHS’s Medicare Advantage Quality Bonus Payment Demonstration Project.
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Confounding Issues about Compounding Pharmacy Regulation*

October 17, 2012 | Blog | By Karen Lovitch

New England Compounding Center (NECC) distributed contaminated syringes that caused a meningitis outbreak – killing fifteen people in fifteen states. Officials estimate that as many as 14,000 patients may have received injections of steroids compounded by NECC from contaminated syringes.
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New Star Ratings for Medicare Advantage and Prescription Drug Plans Go Live

October 12, 2012 | Blog | By Karen Lovitch, Theresa Carnegie

Earlier today, CMS made available its 2013 Medicare Health Plan Quality and Performance Ratings, also called “Star Ratings.” The Star Ratings will assist enrollees during the annual enrollment period that extends from October 15, 2012 to December 7, 2012 and will also play a significant role in determining reimbursement rates for Medicare Advantage Plans.
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HHS OIG Identifies Shortcomings in CMS’s Response to Data Breaches and Medical Identity Theft

October 11, 2012 | Blog | By Karen Lovitch

Yesterday the U.S. Department of Health and Human Services Office of Inspector General (OIG) released the results of a study entitled CMS Response to Breaches and Medical Identity Theft. 
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Corporate Integrity Agreements: OIG Provides Glimpse of the Future

October 11, 2012 | Blog | By Pamela Kramer, Hope Foster

The OIG held a roundtable meeting with representatives from 32 companies that have entered into Corporate Integrity Agreements (CIAs) since 2009. Following from the August 7, 2012, roundtable meeting, this week the OIG published a roundtable paper Focus on Compliance: The Next Generation of Corporate Integrity Agreements. 
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Fiscal Year 2013 Work Plan Highlights OIG’s Medicare Parts C and D Priorities

October 9, 2012 | Blog | By Daria Niewenhous, Theresa Carnegie

Last week, the OIG published its FY 2013 Work Plan. The Work Plan summarizes new and ongoing reviews and activities that the OIG plans to pursue with respect to HHS programs and operations during FY 2013 and beyond.
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State and Federal Pharmaceutical Enforcement Litigation: What’s Next?

October 8, 2012 | Blog | By Karen Lovitch

I recently co-chaired an American Conference Institute (ACI) forum on Pharmaceutical Pricing Litigation, which featured a number of key players who provided their unique perspectives on state and federal litigation involving pharmaceutical manufacturers and their products.
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New York Governor Vetoes Legislation Intended to Conform State Self-Referral Ban to the Stark Law

October 5, 2012 | Blog | By Karen Lovitch

Earlier this week, New York State Governor Andrew Cuomo vetoed legislation that would have brought the State’s restrictions on physician self-referrals (the State Law) in line with the federal ban on self-referrals, which is commonly known as the Stark Law.  
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Reimbursement and Payment Highlights from the HHS OIG's Work Plan*

October 4, 2012 | Blog | By Karen Lovitch

As reported in an earlier post, the U.S. Department of Health and Human Services Office of Inspector General (OIG) has released its Work Plan for Fiscal Year 2013 (Work Plan). 
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HHS OIG Releases Work Plan for FY 2013

October 2, 2012 | Blog | By Karen Lovitch

HHS OIG posted its Work Plan for FY 2013 earlier today. The Work Plan is always of interest to the health care industry because it provides a roadmap of the HHS OIG's priorities for the coming fiscal year. 
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ML Strategies Publishes Weekly Health Care Reform Update on October 1, 2012

October 2, 2012 | Blog | By Daria Niewenhous

ML Strategies has posted its weekly Health Care Reform Update.  This publication provides timely and concise information on  implementation of the Affordable Care Act, and other state and federal administrative and legislative activities related to health care reform.
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